2022-502639-21-00已完成3 期
A Multicenter, Open-Label, Follow-Up Study to Assess the Long-Term Use of Oral Lacosamide in Study Participants Who Completed EP0034 or SP848 and Received Lacosamide Treatment
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 5
- 主要终点
- 1. Incidence of treatment-emergent adverse events (TEAEs) 2. Withdrawals from study due to TEAEs 3. Withdrawals from study due to Serious Adverse Event (SAEs) 4. Modal daily dose during the study 5. Maximum daily dose during the study
研究概览
简要总结
Assess the long-term use of lacosamide oral solution dosed at 2mg/kg/day to 12mg/kg/day when administered to pediatric study participants with epilepsy who have completed NCT01964560 (EP0034) or NCT00938912 (SP848).
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Participant is male or female, aged <6 years at the time of signing the Informed Consent Form (ICF) - Participant has completed participation in NCT01964560 (EP0034) or NCT00938912 (SP848) - Participant is expected to benefit from participation, in the opinion of the Investigator
排除标准
- •Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study - Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol - Participant is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM) - Participant meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for EP0034 or SP848, or is experiencing an ongoing serious adverse event (SAE) - Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study
结局指标
主要结局
1. Incidence of treatment-emergent adverse events (TEAEs) 2. Withdrawals from study due to TEAEs 3. Withdrawals from study due to Serious Adverse Event (SAEs) 4. Modal daily dose during the study 5. Maximum daily dose during the study
1. Incidence of treatment-emergent adverse events (TEAEs) 2. Withdrawals from study due to TEAEs 3. Withdrawals from study due to Serious Adverse Event (SAEs) 4. Modal daily dose during the study 5. Maximum daily dose during the study
次要结局
- Not applicable
研究者
UCB Cares
Scientific
UCB Biopharma
研究点 (5)
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